[4] The most common side effects include wound complications such as skin reactions at the application site, infections, pruritus (itching), and hypersensitivity.

[1] It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound healing and closure.

[1] The US FDA approved birch triterpenes based on evidence from a clinical trial (NCT03068780[1][8]) of 223 participants with dystrophic and junctional epidermolysis bullosa.

[6] The primary endpoint was the proportion of subjects with first complete closure of the target wound by day 45 of the 90-day double-blind phase of the study, based on clinical assessment by the investigator.

[6] The trial was conducted at 49 sites in 26 countries including Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, the Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Romania, Russia, Serbia, Singapore, Spain, Switzerland, the United Kingdom, and the United States.